Thanks everyone for sticking around here. So in June of 2022, Walgreens launched its clinical trial business, which utilizes Walgreens' national retail pharmacy footprint to provide patient recruitment, trial conduct, and real-world evidence services to biopharma sponsors. The company has recently prioritized expanding the services that Walgreens provides through its pharmacy network and its clinical trial business expected to play a central role as it moves forward here. In today's discussion, we're joined by Ramita Tandon, Walgreens' Chief Clinical Trial Officer. Ramita joined Walgreens in 2021, and she's tasked with building out Walgreens' clinical trial capabilities and now has seen the business develop into a profitable operation that serves over 25 manufacturers across 35 trials. Prior to Walgreens, Ramita has spent over 25 years in the life science space, including positions at ICON and Parexel in various roles that focus on disrupting the clinical development cycle and bringing products to the hands of patients faster. So Ramita, thanks for being here with us today. Thanks for having me, Charles. Maybe to start off, can you help us understand what is it that Walgreens is providing in its clinical trials offerings today? You know, like you said, we launched our clinical trials business in June of 2022, with the idea of just redefining that patient experience, and really looking at ways to tackle the issues around lack of patient access and lack of representation that has plagued our industry for a very long time. So, you know, our focus has been just, you know, how do we get access to patients faster? How do we improve the representation in the drug development process? And so since we've launched, you know, back in 2022, I'm pleased to say that, you know, the work that we've been doing with our partners today is proving out that the Walgreens ecosystem and the assets that we're using to help support our pharma partners has been working. We certainly have been helping our pharma partners to find those patients for their trials. But more importantly, the patients that are in these communities that have historically not been represented in research, they're becoming part of the drug development process. And so as we think about the how, you know, from a Walgreens perspective, we wanted to design the business model that would look to sort of solve some of the pain points that pharma faces as they think about their R&D portfolio and as they think about their trials, right? A big part of the pain point is finding patients for trials, getting those trials done in efficient fashion so they can get to the FDA for approval. And so we organized our business model around three key service offerings. The first one is around what we call insights-driven patient recruitment, and that's really accessing the Walgreens', patient access, direct patient access of 100 million lives, and really helping pharma to help identify those right patient populations. Because we sit on a what we call a live breathing network of, you know, a number of patients, we can index those patients by race, gender, ethnicity, social determinants of health, even by zip code. So we're applying a lot of precision of how we find those patients, and because we're a covered entity, it allows us to then outreach, which puts us in a very unique position. So not only can we find those patients, we then have the ability to outreach to those patients directly. And so the insights that we have within the Walgreens ecosystem allows us to really, you know, create more culturally relevant, outreach modalities, because obviously, within Walgreens, we're constantly reaching out to our consumers, our patients. We're using that insights to help us, you know, get patients interested and wanting to participate. So that's that first service line, Charles. The second service line is what we call trial conduct. This is what we've developed to really tackle the issues around accessibility, and we created sort of a flexible set of options because we know from a trials perspective, trial design, patient populations, the disease conditions are not all the same. And as we think about it from a patient's perspective, the communities that we serve across Walgreens are not the same, so the way they consume information is not the same. And so from our side, we built the trial conduct offering to do a couple things. Number one, we're using our pharmacy locations where we have private health rooms, anywhere from 500 sq ft to 5,000 sq ft with multiple exam rooms, that offers patients to come in, first and foremost, be educated about what a clinical trial is, because I can tell you, a number of folks don't even know what clinical research is and the value it has in their own care journey. But then they can go in and get consented. We then take them further in their journey, where they can actually have clinical trial services: screening, diagnostic, and blood draws. And the idea, again, is to be able to tackle the issues around accessibility, because historically, and to some extent today, many patients are unable to get to the academic medical centers or physician practices because they're too far. They can be anywhere from an hour, an hour and a half, and that's posing a lot of barriers for broader participation in research. The second format that we have in place is what we call hybrid. That really sort of brings together the store on-site locations, but also digitizing aspects of the workflow, because we know aspects of clinical trials is becoming digitized, and it provides more convenience for patients to be able to participate. And then the third option is really centered around at home. Today we're running a clinical trial where we actually can take the clinical trial services at a patient's home. We're actually sending out nurses, study coordinators, and other healthcare professionals while the physicians are able to provide the oversight via telehealth. That flexibility allows our patients opportunities to participate and get part of the drug development process. The third service offering that we've put in place to support our pharma partners is what we call real-world evidence informatics. Really, Charles, it's all about just tapping into the, you know, information that we have on our consumers and patients, help pharma as they think about their evidence generation planning, as they think about, you know, retrospectively, they're looking to understand patient populations, treatment, you know, treatment regimens, and then also prospectively, as they're looking to collect data on, you know, whether it's qualitative or quantitative, post-market. So it could be post-market commitment studies, it could be REMS, safety surveillance programs, but our pharma partners are reaching out to us to help in those efforts. And when we think about these three service offering lines, should we think about within certain therapeutic areas that you're best positioned to help pharma in? You know, what therapy areas are you maybe initially focused on? Where could that expand to? Yeah, it's a good question. So, you know, we can work across a wide variety of therapeutic areas. You know, just the ones that are in flight today, you know, we're working on some diagnostic and screening in lung cancer and colon cancer. In fact, we're enrolling up to 50,000 patients across these trials that are coming into our stores for some of these, you know, clinical trial services. We've got diabetes, cardiovascular outcome, heart disease, trials, and certainly vaccination programs. Generally speaking, you know, certainly the general health population type of disease indications make sense for us to be able to support our pharma partners. There are some specialty conditions. You know, certainly we have specialty pharmacies within Walgreens that allows us to tap into that ecosystem to help support our partners. Maybe talk about, you know, the role of the pharmacist in all this. You know, you're bringing in, you know, this kind of services into the pharmacy store itself. Talk about how the pharmacist interacts with it and how do you incorporate it into the workflow, perhaps not to create an undue burden since they have other responsibilities? Yeah, you know, let me just first and start by saying, you know, Walgreens, you know, is an essential part of healthcare, just as it's essential to, you know, retail and pharmacy. And so as we think about our commitment to the clinical trials business at Walgreens, it's really expanding our ability to provide additional healthcare offerings, value-based solutions to our patients and their needs. I mean, these are patients that we're dealing with every single day across this nation. So, you know, as we think about what we do within clinical trials, it really is a natural fit, you know, with our core retail pharmacy business. You know, you heard us, you know, as a company talking about moving forward, you know, providing more focus and investments that will build off of our core capabilities and really start to provide differentiation, and value to our stakeholders, whether they're payers, whether they're healthcare systems, and in this case, in pharma, in a capital-light way. So clinical trials represents a great example of building off our core capabilities in a capital-light fashion. Now, as we think about you know, how we execute a lot of this, you know, as I think about sort of the ingredients of success that we've had in the last two years in some of the growth in clinical trials, it's really around our clinical trials team forging the strong relationships with our retail and our pharmacy colleagues, and you know, that's really in two parts. Number one, you know, our colleagues are working with consumers and patients on a regular basis. They understand how to engage the consumers, you know, what are the right modalities, what are the right engagement models? So we're using those insights to help support pharma as they're looking at ways, novel ways, to reach out to patients to help support their R&D portfolio, and then secondly, we just wanna make sure we're providing a good patient experience for our patients as they participate in clinical trials, particularly the first time, but we are very intentional about how we staff and assign tasks for clinical trials. You know, when we conduct a clinical trial at Walgreens, we bring in clinical trial experts, people who have strong tenure in the space, whether they're coming from pharma, CROs, or SMOs, and they're responsible for designing and executing the clinical trials. In part, it's to make sure that we're adhering to all the compliance regulations that, you know, govern our ecosystem, but more importantly, that we're not providing undue burden to the pharmacist. So that's one example. And the second is, you know, where we have our stores that have been converted as clinical trial centers, we have on-site staff, and they're working closely with the pharmacist to help us identify and just drive awareness about the clinical trials that we're running at Walgreens. You know, case in point, today, when patients are going in to pick up their scripts, and we're running a clinical trial, and a patient might be eligible for that trial, it gets flagged in the pharmacy system, that the pharmacist can see it, that that patient's eligible for that trial. So the pharmacist will then naturally let the patient know that they're eligible for a clinical trial. If they wanna learn more, the information will be on their, in their script bag on a QR code, or they can go talk to one of the clinical research professionals that are in the, in the private health rooms. So again, you know, we're using the pharmacist to really drive awareness and education. And then finally, you know, the role of the pharmacist is absolutely critical for us at Walgreens. You know, we are, you know, intensely focused to make sure that Walgreens is seen as the, a practice setting of choice. We've deployed a national clinical trials training program across the ecosystem. So where pharmacists are interested to become clinical research pharmacists, they have an opportunity to advance their careers. ... that, that's really great and helpful. When we think about sort of the role Walgreens is taking in terms of clinical trials, you've seen other retail pharmacies sort of enter the space, but then kind of quickly exit the space. What do you think separates Walgreens? 'Cause you've built something that's now, it's profitable on its own. What do you think that you guys have done differently that's kind of enabled you to be more successful here? Yeah, well, let me just preface. I mean, we are the only retail pharmacy, you know, out there that's providing a mature set of clinical trial services to our pharma partners today. You know, I think it boils down to the trust, you know, really accessing the full horsepower of Walgreens, the ecosystem, the assets, and stitching in a way that, one, it's capital light, but two, it affords a differentiation to our pharma partners and really helping to solve some of the challenges that they're facing to find patients. But it really boils down to really leveraging the foundation that we have. You know, certainly from a Walgreens perspective, we've, you know, we're a trusted brand in our communities, and we've been a partner in healthcare, really deploying personalized and local care. And that's important as we unlock and deliver some of those services to our pharma partners that are looking at ways to build the trust and rapport within many communities as well themselves. Yeah, and to add on to that, just right, if we think about the reach that Walgreens has into underserved communities, you know, over the past few years, the FDA has clearly made a big push to have, you know, greater representation in clinical trials, particularly of underserved communities. You know, talk about sort of Walgreens' unique positioning and sort of the success you've seen in terms of helping pharma be able to, you know, get to those patients. Yeah. I mean, obviously, we're seeing a big push, you know, from the lawmakers, from the agency, patients, and even payers, you know, that are getting, you know, getting more louder about making sure, you know, sample sizes are enriched, and so when medications are, you know, being dispensed from pharmacies, that they can benefit all patients across the nation, right? So, you know, there's a statistic that the FDA had published about, I think, two, three years ago, that less than 5% of the nation participates in clinical research, and those that participate, 3/4 identify themselves as White. So what that's showing is that we have a significant gap in how these medications are benefiting, you know, the general population. So from a Walgreens perspective, you know, we're in a very unique position. Because we have direct access to diverse patient populations, we're in communities that most are not. It's a natural way to help pharma, be able to, you know, solve some of those, that issue itself. The good news is we're seeing a lot of intentionality behind the design and the operational execution and the need to go after patients in communities that have never been tapped into, in the past. So, it's a big point of differentiation for us as we help support pharma, in this effort. Maybe in terms of, like, any kind of examples of success you've had in terms of being able to reach these patients? Yeah. So we've just completed a number of trials. So as we complete our trials, we publish our case studies out to the public domain so that we can... You know, folks can start to see the role pharmacy has in clinical research. But a recent vaccination study, a phase III study that we enrolled, you know, we enrolled within sixteen weeks of study start. We exceeded all expectations of the referral rate that was expected of us. And then, as we think about just the diverse patient population, we ended up doubling the rate. So, you know, the trial was looking for us to enroll Black and Hispanic populations, and the FDA report in 2020, traditionally, it's around 8%, typically in the single digits. But for that particular trial, we enrolled anywhere from 15%- 18% of patients from Black and African communities and Hispanic and Latina communities. So that's just one example. Our partnership that we announced with Prothena, that we were, you know, looking to help support a phase I potential treatment in Alzheimer's, here's another case where we brought forth, you know, close to 21% of Hispanic and Latina patient populations into that trial. So what that's showing is that because we have access to diverse patient populations, we have the ability to quickly identify those patients and be able to match those patients to trials, faster than, you know, what the industry's been able to do so far. And I'd imagine for pharma, right, because if I remember how the guidance works, they have to go to the agency prior to phase III, right? After phase II, present a plan on, you know, what their patient population will look like. I would imagine, you know, what has sort of been the interest from pharma, as you've kind of put out these cases, you know, is it just mostly inbounds coming into you? Have you or are you kind of reaching out to kind of show them the information? You know, when we launched the business back in 2022, the demand was pretty significant because that was at the time when you know the lawmakers put a provision in the bill around diversity action planning for the industry, for pharma. And so, you know, the ecosystem was then naturally trying to scramble and put together what those diversity action plans would look like and start to go find partners to kind of help fulfill those commitments. So the inbound activity has been pretty significant in terms of you know Walgreens, help us find patients, whether they're in rural, whether they're urban, Deep South, help us find patients that will help us to enrich our sample size. So when we do go to the FDA for review and approval, you know, they're able to present more of an enriched sample size for our final approvals. In the past, you talked about how, you know, when the services that you'll provide pharma is, you want to have, like, a flexible model and, and really have your clients, your customers, pharma, guide you in terms of the sort of services you'll offer. If we think about the three service offerings that you have now, you know, which ones are you mostly doing today? You know, where is the demand from pharma right now, mostly? Yeah, you know, the good news is we're cutting across all three service lines. But, you know, as pharma, you know, comes into our ecosystem for the first time, certainly leveraging our patient recruitment capabilities and the direct access to the patients to help them find those patients to fulfill their commitments to the trials, is just a natural, you know, partner for them. And then, as they, you know, go further downstream and they find those patients, they recognize that, "Boy, we've got to get those patients into our centers." So, you know, we've been very flexible in how we work with them because oftentimes pharma will have designated physician sites or academic medical centers already part of their ecosystem, and then they include Walgreens clinical trial sites as part of that ecosystem so that it becomes convenient for that patient to go in for some of their, you know, basic low-acuity services. So I would say, you know, obviously, in the beginning, we had tremendous amount in patient recruitment, but as we've built the rapport, as we've, you know, published a number of the case studies and the effectiveness that the role of pharmacy plays, it's naturally then allowed them to continue to build on the additional services, you know, for them. But also, Charles, it takes us from these transactional engagements into more strategic partnerships, where then pharma starts to spend more dollars with Walgreens and starts to look at the asset overall and start to become sort of an end-to-end partner as we think about looking at just beyond recruitment and support that trial and their patient throughout that service footprint. Yeah. Speaking of strategic partnerships, you guys recently announced one with BARDA- Yeah ... to drive, I think it comes with a vaccine study, but as well, really kind of looking at innovation for decentralized clinical trials. Maybe sort of in your minds, I think for some investors here, they have an idea of what they think decentralized clinical trials means. Maybe first, you know, how do you—what is—what do you think of when you think of the words decentralized clinical trials? What does that mean to you? What- Yeah. What can it be? It's a good question. You know, from our perspective at Walgreens, you know, decentralizing clinical research is really bringing clinical trials into the communities closer to where the patients are. So, you know, whether it's looking at alternative sites of care, whether it's looking at new digital modalities to engage patients, or in the case of just, you know, delivering at patients' homes, it's trying to make it more personalized, it's making it more convenient, is how we define it, and so, you know, our partnership with BARDA is an exciting one. Obviously, you know, BARDA's goals are very much aligned with where Walgreens is heading with our clinical trials business. They're very focused on, you know, disrupting the current landscape and improving patient access, improving representation in clinical trials. And so, you know, certainly with the capabilities that we've put in place, they see Walgreens as a natural partner to not only support their vaccine trials that we're kicking off, but more importantly, the long-term partnership and the investment up to $100 million is to really build out the infrastructure and using the Walgreens footprint to make trials more accessible and drive more trials into the communities and decentralize the traditional model that has been using, you know, academic medical centers and physician practices that, you know, have been fatigued and struggled to bring, you know, representative patient populations. And keeping those patients retained in trials has been a big struggle as well. Yeah, maybe if you think about it that way. So you announced another partnership with Boehringer Ingelheim, not too long ago. Yeah. Was that what they're looking for when they partnered with you? Right, 'cause, you know, it was a phase III trial. You know, maybe talk about what were the capabilities that they kinda wanted from you, in this case? Yeah. You know, BI, with the same, you know, intentionality in mind around, you know, how do we, you know, disrupt sort of the current landscape that, you know, we've been working through? And how do we find, for this particular phase III study focused on obesity and diabetes, you know, going into communities, particularly looking to recruit Black and Hispanic patient populations in the trials that traditionally are impacted, you know, by obesity here in the U.S. And so, you know, they've partnered with us to help them find those patients, using our community pharmacies as a way to bring those patients, one, to recruit those patients, and then bring them in for some of the trial services on-site. Because, again, in those communities, it's hard to be able to, you know, drive an hour, an hour and a half to a designated academic medical center. So BI made the intentionality and the investment to support, you know, Walgreens' community pharmacies to support their phase III trial. So, I mean, this all sounds great. You know, this looks like there's a lot of demand. Maybe talk about how big can this be? I mean, like, you know, when you... How do you size the market here? What's the opportunity for Walgreens? You know, as we step back and look at the overall, you know, addressable market, certainly, you know, from the types of outsourced services that we're in today from an R&D perspective, is healthy and it's growing. Certainly in the 2023 report that was published by IQVIA, you know, 18% of growth that we're seeing from R&D, you know, large pharma spend in these types of services. And then, as we think about just the overall R&D investments, is about $150 billion, and 50% of that's being spent in outsourced services. So from our perspective, there's tremendous growth for Walgreens to continue down the space and to be able to support pharma and capture these services. And I guess maybe just the thing in the big picture, like it, you know, how you envision this to be a material part of, like, the Walgreens story as we go forward at some point? Yeah, I mean, certainly it is. It's a big part of our overall strategy. As I said, like, you know, it's about building on the core capabilities of the Walgreens ecosystem and the assets and continue to drive value differentiation for our partners. But, you know, as we think about the future of clinical trials and where that's heading, certainly we're gonna continue to see the momentum of decentralization of clinical research and getting closer into the communities and closer where the patients are, and so Walgreens is very uniquely positioned to help support in that movement, in that momentum. We're gonna start to see more of, you know, improving representation in clinical trials and making sure that therapies and, you know, new diagnostics is beneficial for, you know, all patients across the U.S. And again, you know, Walgreens is very well-positioned to support in those efforts. And then maybe lastly, right now we've talked about how you're serving directly to pharma sponsors, but you know, the CRO industry itself is very large. You came from it yourself. Yeah. You know, have you seen them sort of reach out? Because obviously, you know, the group is concerned about sort of maybe some slowdown in demand and some characteristics. And I wonder how much of that is maybe pharma kind of looking for new ways to do things. And what kind of role do you think Walgreens can play supporting even CROs, perhaps? Yeah, you know, we've been tapped by a number of CROs to help them support their efforts to find patients and, you know, help fulfill some of the commitments that they have with their own with their pharma partners. And, you know, I think, you know, when we launched the business, we knew early days, and especially when, you know, pharma was coming to us, that they were looking for alternative ways of finding patients and certainly trying to meet the commitments of the diversity, you know, angle, and finding and looking to find those diverse patient populations. And same thing with CROs. CROs are looking at ways, you know, for Walgreens to help support some of the representation challenges that they too are facing within their own ecosystem. So, you know, we've been very intentional about the partnerships that we've brought into our ecosystem. We wanna make sure that it's advancing our own objectives as we work directly with pharma partners. But certainly, you know, the lens of a CRO is. There's an opportunity for partnership and help support some of the portfolio of studies that they've got within their own ecosystem. Got it. So maybe last question here. You touched a little bit about it before, but look out five, 10 years, what do you think sort of the clinical trial industry looks like? You know, what is, what is the role you see Walgreens kind of fitting into it? Yeah, you know, the role of pharmacy and the pharmacist is gonna be, you know, quite essential. We believe that it's essential to healthcare, just as, like, it's essential in retail and pharmacy, as I said earlier, and you know, that trust, the scale, the accessibility is gonna be quite critical for us to continue to move the momentum so that we can help our pharma partners, you know, fulfill the commitments within their R&D portfolios. You know, decentralization of clinical research is going to be the future as we think about just bringing trials into the communities. Government entities like BARDA certainly is moving down that path. You know, there's entities like NIH that's also looking at ways to go into the communities and get access to patient populations and get them to view as a care option in their overall healthcare journey. So, you know, we've built the model to be very flexible. We're leveraging the full assets and the capabilities of Walgreens to kinda help support the movement and the continued investments in clinical research, particularly in the decentralization of clinical research. Great. Well, I think we'll end it there. Thank you so much, Ramita, for joining us today. Really appreciate all your insights, and thank you, everyone, for being here with us today. That concludes the program for today, and thank you for all being here. We have refreshments out those doors there, and hope you'll stick around and enjoy a drink with us.
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